NCT07500363

Brief Summary

The goal of this study is to test the effectiveness of the FANS-EI program in supporting caregiver engagement in caregiver-mediated early interventions for young children with autism. This study also examines caregiver-perceived social support and self-efficacy and FANS-EI implementation outcomes (feasibility, acceptability, appropriateness).

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
31mo left

Started Apr 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress5%
Apr 2026Dec 2028

First Submitted

Initial submission to the registry

March 9, 2026

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 30, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

March 30, 2026

Status Verified

February 1, 2026

Enrollment Period

2 years

First QC Date

March 9, 2026

Last Update Submit

March 24, 2026

Conditions

Autism

Keywords

Early InterventionCaregiver Mediated Interventionscaregiver engagementmobile healthsocial support

Outcome Measures

Primary Outcomes (1)

  • Parent Participatory Engagement Measure

    The 5-item Parent Participatory Engagement Measure (PPEM) examines caregiver comfort with, engagement and participation in the intervention.

    Weekly for 6 months

Secondary Outcomes (6)

  • Caregiver Buy-In to EI

    baseline, 6 months

  • Parenting Sense of Competence Scale

    Baseline, 6 months

  • Social Support Index

    Baseline, 6 months

  • Acceptability of Intervention Measure

    6 months

  • Intervention Appropriateness Measure

    6 months

  • +1 more secondary outcomes

Other Outcomes (6)

  • Coaching Practices Rating Scales

    Baseline, 2nd and 4th months, 6 months

  • Frequency of contact

    Baseline, weekly until exit at 6 months

  • Vineland Adaptive Behavior Scales-3

    Baseline, 6 months

  • +3 more other outcomes

Study Arms (2)

Treatment as usual

ACTIVE COMPARATOR

Families receive early intervention as usual

Behavioral: Early Intervention

FANS-EI

EXPERIMENTAL

FANS-EI supporters and caregivers will receive text messages from the research team three times a week. The messages to supporters mirror the caregiver messages and will include educational/motivational messages. Supporter will receive asynchronized general educational materials about autism (including characteristics of autism, understanding child's behaviors, etc.). Supporters will have the option, but will not be required, to attend EI sessions with the family if the family agrees.

Behavioral: FANS-EI

Interventions

FANS-EIBEHAVIORAL

Social support related text messages delivered to supporters and caregivers; asynchronized educational materials for supporters.

FANS-EI
Early InterventionBEHAVIORAL

Treatment as usual provided by community-based autism early intervention agencies

Treatment as usual

Eligibility Criteria

Age12 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Providers' eligibility criteria 1. currently providing early intervention services, including a caregiver-coaching component 2. having at least 1 child in the autism service classification on their caseload. Caregiver/Child Dyads eligibility criteria 1. child is 12-60 months of age at the time of enrollment 2. child has a diagnosis or high likelihood of autism 3. a family/friend supporter of the caregiver is willing to be part of the study 4. caregivers and supporters speak English

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of California, Davis MIND Institute

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Autistic Disorder

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2026

First Posted

March 30, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

March 30, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)